Pharmaceutical Data Integrity

Instructor: Mark Powell
Product ID: 706101
Training Level: Intermediate
  • Duration: 60 Min
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2019

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

In their guidance on data integrity, all regulators emphasize a risk-based approach to ensure that effort is focused on the greatest risks. This approach should help companies to achieve compliance with regulators’ expectations without committing a disproportionate amount of human or financial resource. This webinar will explain to attendees why data integrity is so important and spell out some of the common honest mistakes that could lead to regulatory enforcement action. The risk-based approach recommended by regulators is also explained in detail.

Areas Covered in the Webinar:

  • Data integrity myths
  • Historical background
  • Definition of data integrity
  • Current regulatory approach
    • Guidance
    • Static and dynamic records
    • Non-conformance trends
    • Example enforcement letters
  • Data integrity risks in the analytical process
  • Conducting a data integrity risk assessment
  • Common causes of data integrity breaches
  • Practical tips on achieving compliance

Who Will Benefit:

  • Quality assurance professionals
  • Consultants
  • GMP auditors
  • Laboratory management
  • Contract laboratories
  • Personnel responsible for data review

From Pharmaceutical manufacturers, contract laboratories

Instructor Profile:
Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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